HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-05

Study Completion Date

2017-09-01

Brief Summary

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Hepatitis B virus (HBV) infection remains difficult to eradicate with about 240 million people living with HBV chronic infection. HBsAg clearance, correlated with a good clinical prognosis, is difficult to achieve even with antiviral treatments (3-14 %). HBV envelope proteins are essential for entry into hepatocyte and are targeted by the immune system. Molecular characteristics of HBV envelope proteins may favour better viral fitness at the entry step into hepatocytes and/or HBV escape from host immunity. Here we investigated whether variability of HBV envelope proteins can contribute to the differential responses to anti-HBV treatment in patients with HBsAg clearance or persistence.

Detailed Description

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Our study is a retrospective study of patients with chronic hepatitis B virus, selected exclusively at the University Hospital Center of Nancy in the Department of Hepato-Gastroenterology (HGE). the patient inclusion criteria were as follows: Adult patients with chronic hepatitis B, treated with nucleos(t)ide analogues, mono-infected with HBV (without co-infection with HCV, HIV and HDV). For each patient included, biological, clinical and therapeutic data were collected retrospectively. Patients with loss of viral load on treatment were included in this study. Among them, patients showed either a clearance of HBsAg on treatment ("responders") or the control patients showed a persistence of HBsAg on treatment ("non-responders", control patients).

Conditions

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Hepatitis B, Chronic

Keywords

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Hepatitis B virus PreS/S variability Anti-HBV treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* adults
* patients with chronic hepatitis B
* treated with nucleos(t)ide analogues
* mono-infected with HBV (without co-infection with HCV, HIV and HDV)

Exclusion Criteria

* minor
* pregnant women
* patients with VHC or VHD

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DC 2013-1801

Identifier Type: -

Identifier Source: org_study_id